Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
ID05821075

Comparative Study of Prednisolone and Cerebrolysin Treatments for Bell's Palsy

Led by October 6 University · Updated on 2025-07-31

90

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Bell's palsy is a common facial nerve disorder causing weakness or paralysis on one side of the face. This research evaluates the effects of two treatments, Prednisolone and Cerebrolysin, to study how well Cerebrolysin helps nerve regeneration compared to corticosteroids. The trial is a randomized, double-blind study sponsored by October 6 University, focusing on adults aged 18 to 60 years with acute unilateral facial palsy of unknown cause. Participants will be assigned to one of three treatment groups: Prednisolone alone, Cerebrolysin alone, or a combination of both. Prednisolone is given as a 60 mg tablet once daily for 5 days followed by a tapering dose, while Cerebrolysin is administered intramuscularly at 10 mg daily for 3 weeks. The study monitors changes in facial nerve function over three weeks using standardized grading systems. During the study, participants will be assessed at baseline, after 1 week, and after 3 weeks using the House-Brackmann and Sunnybrook grading scales to measure facial nerve recovery. Researchers will track progress and safety throughout the trial period. Total participation time includes initial screening and treatment phases, with follow-up evaluations to measure treatment outcomes and monitor for any complications.

CONDITIONS

Brief Title

Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 60 years
  • Unilateral acute facial palsy of no identifiable cause
Not Eligible

You will not qualify if you...

  • Recurrent facial Bell's palsy
  • Pregnancy
  • Diabetes
  • Epilepsy
  • Severe hypertension
  • Renal or hepatic disease
  • Gastric or duodenal ulcer
  • Presence of acute otitis media or ipsilateral chronic otitis
  • Recent head injury
  • Psychiatric disease
  • Contraindications for corticosteroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 weeks

Participants receive either Prednisolone tablets daily for 5 days with tapering dose or intramuscular Cerebrolysin daily for 3 weeks, or a combination of both.

Visits at baseline, after 1 week, and after 3 weeks (in-person)

Trial Site Locations

Total: 1 location

1

October 6 university hospital

Giza, Egypt, 12573

Actively Recruiting

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Research Team

E

Engy Wahsh

M

mohamed rez

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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